Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Oral Mucositis

In brief

The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for head and neck cancer.

Key facts

Study ID: NCT01400620
Run by: Izun Pharma Ltd
People needed: 110
Starts: 2012-03-01
Expected to finish: 2017-01-01
Last updated by the study team: 2018-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

diagnosis of head and neck cancer
planned treatment course to include Cisplatin and radiation therapy, cumulative prescription dose between 50-70 Gy
able to eat at least soft solids
normal cardiac function
able to perform oral rinse

You may not qualify if…

Induction chemotherapy regimen
life threatening allergic reaction to food and/or drugs
history of any other primary malignancy diagnosed within the past 5 years
prior radiation to the sites to be treated
active infections of the oral cavity

Where it is running

UF Health Cancer Center — Gainesville, Florida, United States
University of Miami-Sylvester CCC Clinical Research Services — Miami, Florida, United States
Mount Sinai Beth Israel - Phillips Ambulatory Care Center — New York, New York, United States
NYU Clinical Cancer Center — New York, New York, United States
Soroka Medical Center — Beersheba, Israel
Rambam Medical Center — Haifa, Israel
Rabin Medical Center - Beilinson Campus — Petah Tikva, Israel
Sourasky Medical Center — Tel Aviv, Israel
Assuta Medical Center — Tel Aviv, Israel
Sheba Medical Center — Tel Litwinsky, Israel

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.